BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1234053 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04204
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: "OVER 18". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE THE GUIDE WIRE BECAME STUCK IN THE MICRO CATHETER. THE 99% STENOSED, CALCIFIED LESION WAS IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A PT2 MODERATE SUPPORT 185CM GUIDE WIRE WAS BEING USED WITH A NON-BSC MICRO CATHETER AS GUIDE WIRE SUPPORT. INITIALLY, THE GUIDE WIRE WAS COMPATIBLE WITH THE MICRO CATHETER; HOWEVER, LATER DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND THE GUIDE WIRE BECAME "STUCK" IN THE MICRO CATHETER. THE PHYSICIAN WAS ABLE TO SEPARATE THE DEVICES BY "FORCIBLY" REMOVING THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDE WIRE AND NON-BSC MICRO CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC MODERATE, 185, STRAIGHT, 1-PACK 11769010

    Patients

    Seq Age Sex Outcome Treatment
    1 FINE CROSS MICRO CATHETER| WHISPER GUIDE WIRE